EP3829671A4 - INTRAVASCULAR PUMP WITH PROXIMAL AND DISTAL SENSORS, PRESSURE OR FLOW AND DISTAL SENSOR MONITORING - Google Patents

INTRAVASCULAR PUMP WITH PROXIMAL AND DISTAL SENSORS, PRESSURE OR FLOW AND DISTAL SENSOR MONITORING Download PDF

Info

Publication number
EP3829671A4
EP3829671A4 EP19844401.0A EP19844401A EP3829671A4 EP 3829671 A4 EP3829671 A4 EP 3829671A4 EP 19844401 A EP19844401 A EP 19844401A EP 3829671 A4 EP3829671 A4 EP 3829671A4
Authority
EP
European Patent Office
Prior art keywords
distal
proximal
flow sensors
sensor tracking
intravascular pump
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP19844401.0A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3829671A1 (en
Inventor
Joseph P. Higgins
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cardiovascular Systems Inc
Original Assignee
Cardiovascular Systems Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cardiovascular Systems Inc filed Critical Cardiovascular Systems Inc
Publication of EP3829671A1 publication Critical patent/EP3829671A1/en
Publication of EP3829671A4 publication Critical patent/EP3829671A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/408—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
    • A61M60/411—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
    • A61M60/414—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor transmitted by a rotating cable, e.g. for blood pumps mounted on a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/13—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/237—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • A61M60/523—Regulation using real-time patient data using blood flow data, e.g. from blood flow transducers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • A61M60/531—Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804—Impellers
    • A61M60/806—Vanes or blades
    • A61M60/808—Vanes or blades specially adapted for deformable impellers, e.g. expandable impellers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/81—Pump housings
    • A61M60/812—Vanes or blades, e.g. static flow guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/81—Pump housings
    • A61M60/816—Sensors arranged on or in the housing, e.g. ultrasound flow sensors

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Mechanical Engineering (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Medical Informatics (AREA)
  • External Artificial Organs (AREA)
  • Transplantation (AREA)
EP19844401.0A 2018-07-30 2019-07-30 INTRAVASCULAR PUMP WITH PROXIMAL AND DISTAL SENSORS, PRESSURE OR FLOW AND DISTAL SENSOR MONITORING Withdrawn EP3829671A4 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862711766P 2018-07-30 2018-07-30
US16/524,548 US11013904B2 (en) 2018-07-30 2019-07-29 Intravascular pump with proximal and distal pressure or flow sensors and distal sensor tracking
PCT/US2019/044069 WO2020028320A1 (en) 2018-07-30 2019-07-30 Intravascular pump with proximal and distal pressure or flow sensors and distal sensor tracking

Publications (2)

Publication Number Publication Date
EP3829671A1 EP3829671A1 (en) 2021-06-09
EP3829671A4 true EP3829671A4 (en) 2022-04-27

Family

ID=69179327

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19844401.0A Withdrawn EP3829671A4 (en) 2018-07-30 2019-07-30 INTRAVASCULAR PUMP WITH PROXIMAL AND DISTAL SENSORS, PRESSURE OR FLOW AND DISTAL SENSOR MONITORING

Country Status (5)

Country Link
US (1) US11013904B2 (ja)
EP (1) EP3829671A4 (ja)
JP (1) JP7047184B2 (ja)
CN (1) CN112533662A (ja)
WO (1) WO2020028320A1 (ja)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11511103B2 (en) 2017-11-13 2022-11-29 Shifamed Holdings, Llc Intravascular fluid movement devices, systems, and methods of use
DE102018201030A1 (de) 2018-01-24 2019-07-25 Kardion Gmbh Magnetkuppelelement mit magnetischer Lagerungsfunktion
CN112004563B (zh) 2018-02-01 2024-08-06 施菲姆德控股有限责任公司 血管内血泵以及使用和制造方法
DE102018207611A1 (de) 2018-05-16 2019-11-21 Kardion Gmbh Rotorlagerungssystem
DE102018208541A1 (de) 2018-05-30 2019-12-05 Kardion Gmbh Axialpumpe für ein Herzunterstützungssystem und Verfahren zum Herstellen einer Axialpumpe für ein Herzunterstützungssystem
DE102018211327A1 (de) 2018-07-10 2020-01-16 Kardion Gmbh Laufrad für ein implantierbares, vaskuläres Unterstützungssystem
DE102018212153A1 (de) 2018-07-20 2020-01-23 Kardion Gmbh Zulaufleitung für eine Pumpeneinheit eines Herzunterstützungssystems, Herzunterstützungssystem und Verfahren zum Herstellen einer Zulaufleitung für eine Pumpeneinheit eines Herzunterstützungssystems
WO2021011473A1 (en) 2019-07-12 2021-01-21 Shifamed Holdings, Llc Intravascular blood pumps and methods of manufacture and use
WO2021016372A1 (en) 2019-07-22 2021-01-28 Shifamed Holdings, Llc Intravascular blood pumps with struts and methods of use and manufacture
US11724089B2 (en) 2019-09-25 2023-08-15 Shifamed Holdings, Llc Intravascular blood pump systems and methods of use and control thereof
DE102020102474A1 (de) 2020-01-31 2021-08-05 Kardion Gmbh Pumpe zum Fördern eines Fluids und Verfahren zum Herstellen einer Pumpe
US20230201558A1 (en) * 2020-05-29 2023-06-29 Shifamed Holdings, Llc Intravascular blood pumps
US20240115849A1 (en) * 2021-02-10 2024-04-11 Shifamed Holdings, Llc Catheter blood pumps with collapsible pump housing and sensor system
CN118215523A (zh) * 2021-11-16 2024-06-18 波士顿科学国际有限公司 包括近侧压力传感器的经皮循环支持装置
EP4433137A1 (en) * 2021-11-16 2024-09-25 Boston Scientific Scimed Inc. Percutaneous circulatory support device including proximal pressure sensor
CN114870241B (zh) * 2021-12-03 2024-08-27 深圳核心医疗科技股份有限公司 驱动装置和血泵
CN117138222A (zh) * 2022-05-24 2023-12-01 上海微创心力医疗科技有限公司 导管泵的放置位置的判断方法、系统、电子设备及介质
CN115701800B (zh) * 2022-09-05 2024-06-11 心擎医疗（苏州）股份有限公司 在线即时获取血液参数的体外式血泵系统

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6176822B1 (en) * 1998-03-31 2001-01-23 Impella Cardiotechnik Gmbh Intracardiac blood pump
US20150141842A1 (en) * 2012-04-27 2015-05-21 Abiomed Europe Gmbh Intravascular rotary blood pump
WO2015160943A1 (en) * 2014-04-15 2015-10-22 Thoratec Corporation Sensors for catheter pumps
WO2017214118A1 (en) * 2016-06-06 2017-12-14 Abiomed, Inc. Blood pump assembly having a sensor and a sensor shield

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4625712A (en) 1983-09-28 1986-12-02 Nimbus, Inc. High-capacity intravascular blood pump utilizing percutaneous access
US4969458A (en) 1987-07-06 1990-11-13 Medtronic, Inc. Intracoronary stent and method of simultaneous angioplasty and stent implant
US4886062A (en) 1987-10-19 1989-12-12 Medtronic, Inc. Intravascular radially expandable stent and method of implant
US5019090A (en) 1988-09-01 1991-05-28 Corvita Corporation Radially expandable endoprosthesis and the like
US4964864A (en) 1988-09-27 1990-10-23 American Biomed, Inc. Heart assist pump
US4950227A (en) 1988-11-07 1990-08-21 Boston Scientific Corporation Stent delivery system
US4969865A (en) * 1989-01-09 1990-11-13 American Biomed, Inc. Helifoil pump
US4856516A (en) 1989-01-09 1989-08-15 Cordis Corporation Endovascular stent apparatus and method
JPH0636821B2 (ja) 1990-03-08 1994-05-18 健二 山崎 体内埋設形の補助人工心臓
US5161547A (en) 1990-11-28 1992-11-10 Numed, Inc. Method of forming an intravascular radially expandable stent
US5314472A (en) 1991-10-01 1994-05-24 Cook Incorporated Vascular stent
US5776183A (en) 1996-08-23 1998-07-07 Kanesaka; Nozomu Expandable stent
DE69739257D1 (de) 1996-10-04 2009-03-26 United States Surgical Corp Kreislaufunterstützungssystem
DE10059714C1 (de) 2000-12-01 2002-05-08 Impella Cardiotech Ag Intravasale Pumpe
US7393181B2 (en) 2004-09-17 2008-07-01 The Penn State Research Foundation Expandable impeller pump
US20090112312A1 (en) * 2007-02-26 2009-04-30 Larose Jeffrey A Intravascular ventricular assist device
JP2015534853A (ja) * 2012-11-06 2015-12-07 クイーン メアリ ユニバーシティ オブ ロンドン 機械的循環補助
GB201219958D0 (en) 2012-11-06 2012-12-19 Queen Mary Innovation Ltd Mechanical circulatory support
EP3324840A4 (en) 2015-07-20 2019-03-20 Tc1 Llc MEASURING TEST STRIPS FOR FLOW ESTIMATION

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6176822B1 (en) * 1998-03-31 2001-01-23 Impella Cardiotechnik Gmbh Intracardiac blood pump
US20150141842A1 (en) * 2012-04-27 2015-05-21 Abiomed Europe Gmbh Intravascular rotary blood pump
WO2015160943A1 (en) * 2014-04-15 2015-10-22 Thoratec Corporation Sensors for catheter pumps
WO2017214118A1 (en) * 2016-06-06 2017-12-14 Abiomed, Inc. Blood pump assembly having a sensor and a sensor shield

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2020028320A1 *

Also Published As

Publication number Publication date
WO2020028320A1 (en) 2020-02-06
JP7047184B2 (ja) 2022-04-04
EP3829671A1 (en) 2021-06-09
JP2021524355A (ja) 2021-09-13
CN112533662A (zh) 2021-03-19
US11013904B2 (en) 2021-05-25
US20200030510A1 (en) 2020-01-30

Similar Documents

Publication Publication Date Title
EP3829671A4 (en) INTRAVASCULAR PUMP WITH PROXIMAL AND DISTAL SENSORS, PRESSURE OR FLOW AND DISTAL SENSOR MONITORING
EP3612082A4 (en) NON-INVASIVE MEASUREMENT AND MONITORING OF BLOOD PRESSURE
EP3860675A4 (en) INTRAVASCULAR BLOOD PUMPS AND METHODS OF USE
EP3640578A4 (en) STRESS GAUGE, PRESSURE SENSOR AND MEDICAL INTERVENTION CATHETER
WO2015102951A3 (en) Catheter or guidewire device including flow sensing and use thereof
EP3579894B8 (de) Katheterpumpe mit antriebseinheit und katheter
EP4034192A4 (en) INTRAVASCULAR BLOOD PUMP SYSTEMS AND METHODS OF USE AND CONTROL THEREOF
EP3621512A4 (en) IMPLANTABLE SENSOR FOR EXTRA COMPARTMENT PRINTING
WO2016014987A3 (en) Long-term implantable monitoring system & methods of use
WO2008042347A3 (en) Smart balloon catheter
EP4077947A4 (en) INTRAVASCULAR BLOOD PUMPS, MOTORS AND FLUID CONTROL
EP3449419A4 (en) DETECTION OF ULTRASOUND DIGITAL IMPRESSIONS AND MANUFACTURE OF SENSORS
EP3109629A3 (en) Sensor with memory storing calibration information
EP3805710A4 (en) COMBINED TEMPERATURE AND PRESSURE SENSOR
EP3534786A4 (en) NON-INVASIVE BLOOD PRESSURE SENSOR
EP3688474A4 (en) SENSOR CALIBRATION TAKING INTO ACCOUNT SUBJECT-DEPENDENT VARIABLES AND / OR BODY POSITIONS
IL240460B (en) Capacitive flexible pressure sensor and breathing monitoring using it
EP4143532A4 (en) INTRAVASCULAR BLOOD PUMPS AND THEIR CONTROL
EP3843620A4 (en) SELF-CALIBRATED, CUFFLESS, NON-INVASIVE BLOOD PRESSURE MONITOR
EP3576613A4 (en) CRYOGENIC BALLOON CATHETER SYSTEM WITH SENSOR ARRANGEMENT
EP3863521A4 (en) DEVICE COMPRISING ULTRASOUND, AUSCULTATION AND AMBIENT NOISE SENSORS
EP3424417A4 (en) BLOOD FLOW SENSOR AND BLOOD FLOW MEASURING DEVICE
EP3751247A4 (en) PRESSURE SENSOR AND ELECTROPHYSIOLOGICAL CATHETER
EP3131460A4 (en) Flow rate sensor system and method for non-invasively measuring the flow rate of a bodily fluid
EP3751243A4 (en) BUILT-IN PHYSIOLOGICAL SIGNAL DETECTION SENSOR

Legal Events

Date Code Title Description
STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE

PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE

17P Request for examination filed

Effective date: 20201124

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)
REG Reference to a national code

Ref country code: DE

Ref legal event code: R079

Free format text: PREVIOUS MAIN CLASS: A61M0001100000

Ipc: A61M0001000000

A4 Supplementary search report drawn up and despatched

Effective date: 20220328

RIC1 Information provided on ipc code assigned before grant

Ipc: A61M 60/00 20210101ALI20220322BHEP

Ipc: A61M 1/00 20060101AFI20220322BHEP

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: EXAMINATION IS IN PROGRESS

17Q First examination report despatched

Effective date: 20230206

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20230817